Z-0289-2018Class II

TomoHDA(R) System, Model Number 1018286

Name: Z-0289-2018 TomoHDA(R) System, Model Number 1018286
Creator: Accuray Incorporated
Published: 2017-11-17
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2017-11-17 / Terminated / root cause: software

FDA source

Accuray Incorporated began a recall of TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and... on 2017-11-17. FDA classified it as Class II and gives the reason as "Uncontrolled couch Z-axis movement (descent)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0289-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Posted: 2017-12-26
Terminated: 2021-07-25
Recalling firm: Accuray Incorporated
Product: TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Uncontrolled couch Z-axis movement (descent)
Root cause tag: software
FDA root cause: Software design
Action: Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated the following: "Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series software version 2.1.2 (Hi Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem." For questions contact Accuray Customer Support by phoning the regional support lines.
Quantity in commerce: 87 units
Distribution: Worldwide Distribution
Product codes and lots: Serial Numbers: 110033 110137 110155 110206 110221 110290 110318 110348 110353 110360 110364 110384 110408 110410 110411 110452 110457 110463 110473 110475 110476 110477 110478 110479 110481 110483 110484 110485 110486 110487 110488 110489 110490 110492 110493 110496 110498 110500 110502 110513 110514 110515 110516 110518 110520 110521 110523 110524 110526 110529 110530 110535 110538 110542 110543 110550 110551 110557 110559 110560 110561 110564 110567 110571 110572 110575 110580 110582 110583 110584 110585 110586 110587 110588 110593 110598 110599 110600 110603 110604 110605 110609 110610 110612 110613 110614 110616

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0289-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0286-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-26
Z-0287-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-26
Z-0288-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-26
Z-0289-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-26

Product code IYE

K121934Class IITomotherapy Treatment SystemAccuray Incorporated / cleared 2012-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)